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0001144204-17-013840.txt : 201703100001144204-17-013840.hdr.sgml : 2017031020170310073042ACCESSION NUMBER:0001144204-17-013840CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:26CONFORMED PERIOD OF REPORT:20170310ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20170310DATE AS OF CHANGE:20170310

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:EYEGATE PHARMACEUTICALS INCCENTRAL INDEX KEY:0001372514STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:000000000STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-36672FILM NUMBER:17680175

BUSINESS ADDRESS:STREET 1:271 WAVERLEY OAKS ROADSTREET 2:SUITE 108CITY:WALTHAMSTATE:MAZIP:02452BUSINESS PHONE:781-788-9043

MAIL ADDRESS:STREET 1:271 WAVERLEY OAKS ROADSTREET 2:SUITE 108CITY:WALTHAMSTATE:MAZIP:02452

8-K1v461507_8k.htmFORM 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM8-K

CURRENT REPORT PURSUANT

TO SECTION13 OR 15(d)OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported):March 10, 2017

EYEGATE PHARMACEUTICALS, INC.

(Exact name of registrant as specified inits charter)

Delaware

(State or other jurisdiction of incorporation)

001-36672 98-0443284

(Commission File Number) (IRS Employer Identification No.)

271 Waverley Oaks Road
Suite 108
Waltham, MA 02452

(Address of principal executive offices) (Zip Code)

(781) 788-8869

(Registrants telephone number, includingarea code)

Check the appropriate box below if the Form8-K filingis intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

oWritten communications pursuant to Rule425 underthe Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule14a-12 underthe Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule14d-2(b)underthe Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule13e-4(c)underthe Exchange Act (17 CFR 240.13e-4(c))

Item 7.01.Regulation FD Disclosure.

EyeGate Pharmaceuticals, Inc. (the Company) herebyfurnishes the updated investor presentation attached as Exhibit 99.1 to this Current Report on Form 8-K, which the Company mayuse in presentations to investors from time to time.

The information furnished pursuant to Item 7.01, including Exhibit99.1, shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended(the Exchange Act) and will not be deemed to be incorporated by reference into any filing under the Securities Actof 1933, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.

The information furnished in this report, including Exhibit99.1, shall not be deemed to constitute an admission that such information or exhibit is required to be furnished pursuant to RegulationFD or that such information or exhibit contains material information that is not otherwise publicly available. In addition, theCompany does not assume any obligation to update such information or exhibit in the future.

Item 9.01.Financial Statementsand Exhibits.

(d)Exhibits.

The Company hereby files the following exhibit:

99.1Presentation of the Company,dated as of March 10, 2017.

2

SIGNATURES

Pursuant to the requirements of the SecuritiesExchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

EYEGATE PHARMACEUTICALS, INC.

By: /s/ Stephen From

Stephen From

President and Chief Executive Officer

Date: March 10, 2017

3

Exhibit Index

99.1Presentation of the Company,dated as of March 10, 2017.

4

EX-99.12v461507_ex99-1.htmEXHIBIT 99.1

Exhibit 99.1

EyeGate Pharmaceuticals, Inc. Providing innovative products that enhance drug efficacy and patient compliance to improve vision Corporate Presentation

1 Forward Looking Statements Some of the matters discussed in this presentation contain forward - looking statements that involve significant risks and uncertainties, including statements relating to the prospects for the Companys lead product EGP - 437, for the timing and outcome of the Companys clinical trials, the potential approval to market EGP - 437, and the Companys capital needs. Actual events could differ materially from those projected in this presentation and the Company cautions investors not to rely on the forward - looking statements contained in, or made in connection with, the presentation. Among other things, the Companys clinical trials may be delayed or may eventually be unsuccessful. The Company may consume more cash than it currently anticipates and faster than projected. Competitive products may reduce or eliminate the commercial opportunities of the Companys product candidates. If the U.S. Food and Drug Administration or foreign regulatory agencies determine that the Companys product candidates do not meet safety or efficacy endpoints in clinical evaluations, they will not receive regulatory approval and the Company will not be able to market them. Operating expense and cash flow projections involve a high degree of uncertainty, including variances in future spending rate due to changes in corporate priorities, the timing and outcomes of clinical trials, regulatory and developments and the impact on expenditures and available capital from licensing and strategic collaboration opportunities. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to significantly alter, delay, scale back or discontinue operations. Additional risks and uncertainties relating to the Company and its business can be found in the Risk Factors section of the Companys Annual Report on Form 10 - K filed with the SEC on February 23, 2017. The Company undertakes no duty or obligation to update any forward - looking statements contained in this presentation as a result of new information, future events or changes in the Companys expectations, except as required by applicable law.

2 Company Overview Ophthalmology company (NASDAQ: EYEG) Platform 1: Crosslinked HA (eye drop formulation) Corneal Epithelial Defects: Positive results announced from pilot clinical trial FDA De Novo 510(k) filing by year - end 2017 European CE Mark by year - end 2017 Platform 2: Proprietary delivery system (delivering EGP - 437: corticosteroid) Cataract Surgery: Phase 2 trial to be initiated Q2 2017 Supplemental NDA filing H2 2018 Anterior Uveitis: Second Phase 3 underway NDA submission year - end 2017 Licensed to Valeant Pharmaceuticals (Bausch + Lomb)

Clinical Pipeline 3 Iontophoresis Crosslinked HA Two platforms in the clinic with expected FDA filings by year - end 2017 Crosslinked HA: OBG Iontophoresis: EGP - 437 Product Indication Stage Targeted Filing Dates Large Corneal Epithelial Defects Pilot Trial completed in patients having undergone photorefractive keratectomy (PRK): Positive data announced Next Trial: Initiation Q2 17 510(K) De Novo filing targeted for year-end 2017 CE Mark targeted for year-end 2017 OBG Crosslinked HA EGP-437 Iontophoresis Anterior Uveitis 2nd Phase 3 Pivotal Trial: Enrolling NDA filing targeted for year-end 2017 Cataract Surgery Phase 1b/2a completed: Positive data announced Initiating Phase 2 Trial Believe only one Phase 3 trial required NDA supplemental filing targeted for H2 2018

4 Hyaluronic Acid Hyaluronic acid is a naturally occurring compound in the body ~15 grams of HA in an adult human body About 50% in the skin (promotes wound healing), also in the synovial fluid (natural lubricant) Rapidly degrades: one - third is naturally turned - over (degraded and synthesized) every day Properties High - molecular weight HA is non - immunogenic HA binds up to 1,000 times its volume in water HAs functions include: hydration, lubrication of joints, and providing a meshwork for cell migration HA approved for derm and osteoarthritis in the U.S. and for dry eye ex - U.S. HA approved in U.S. as a dressing for wound and burn management (dermatology) HA injections approved in the U.S. to treat knee pain caused by osteoarthritis HA eye drops are the standard of care in Europe and Asia for symptoms and signs of dry eye and/or ocular surface damage, due to diseases such as superficial keratitis, Sjgren syndrome or primary dry eye syndrome and wound healing.

5 CMHA - S Platform Differentiating CMHA - S vs HA CMHA - S is a crosslinked version of HA HA crosslinking prevents degradation and increases viscosity Crosslinking HA creates a 3D structure that stabilizes the molecule ( resists degradation ) Adheres longer to the ocular surface (90 minutes) Higher viscosity that thins with blinking and is non blurring Scaffolding matrix that protects the ocular surface EyeGates first CMHA - S product is a topical application (eye drop) for treating a wide variety of ocular surface pathologies EyeGate Ocular Bandage Gel or OBG (eye drop): a 0.75% concentration of crosslinked HA Corneal epithelial defects can lead to ocular infections, inflammation, corneal neovascularization, and vision loss if not treated promptly and healed rapidly Crosslinked Hyaluronic Acid

EyeGate OBG proven efficacy and safety across several animal studies (already commercialized in vet. space) Efficacy of CMHA - S has been demonstrated in various animal pathology models: Post traumatic corneal stromal ulcers (dogs and cats) Corneal abrasion and alkali burn injuries (rabbits) Dry eye (rabbits and dogs) 1. EyeGate has human ophthalmic rights only. Visit http://www.bayerdvm.com/show.aspx/remend - cross - linking - video Commercially available as a veterinary device Manufactured by SentrX Animal Care Sold in the U.S. and certain European countries by Bayer Animal Health as Remend Corneal Repair 1 5 years in dogs, cats and horses, with an excellent safety profile 6 Molly a 12 year old cat with a non - healing corneal defect Non - healing at 42 days (A) Ulcer healing after 12 days of using 0.75% CMHA - S (B) EyeGate Ocular Bandage Gel (OBG)

Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits 1 CMHA - S treated cornea exhibited more normal epithelial and stromal organization than control group 7 1. Guanghui Yang, Ladan Espandar , Nick Mamalis and Glenn D. Prestwich, Veterinary Ophthalmology 2010 A. Fluorescein staining of corneal epithelial abrasions B. Quantitative analysis at 24 hrs ; 49 vs 83% complete P < 0.01 Histology of alkali burn healing A. Control at Day 12 central wound with unhealed corneal epithelium B. CMHA - S treated central epithelium and corneal stroma showing a better organization than control Wound closure rate of central corneal epithelium faster in CMHA - S group Abrasion: Wound closure complete by 48 hours with CMHA - S Burns: Complete re - epithelization at Day 12 for CMHA - S but not for control

Announced positive data evaluating ability of EyeGate OBG to accelerate corneal surface re - epithelialization following bilateral photorefractive keratectomy (PRK) PRK is an efficacious alternative for patients seeking surgical correction of refractive errors who are poor LASIK candidates PRK surgery provides several advantages as indication to evaluate OBGs ability Larger epithelial defects : All eyes randomized at time zero with same size defect Homogenous population: All eyes healthy (i.e. normal stem cell function) and will heal at ~ same rate 39 subjects randomized to one of 3 groups: both eyes received the same treatment Group 1: EyeGate Ocular Bandage Gel QID for 2 weeks after surgery Group 2: EyeGate Ocular Bandage Gel QID for 2 weeks after surgery in combination with a Bandage Contact Lens (BCL) Group 3: BCL and preservative - free artificial tears 8 EyeGate Ocular Bandage Gel (OBG) First Human Clinical Trial Completed

Excellent safety and tolerability No adverse events in OBG arm No corneal haze out to Day 28 ~30% more patients healed by Day 3 with OBG than standard - of - care (BCL+AT) Additionally, wound size was ~53% smaller as early as Day 1 (24 hrs post surgery) with OBG Next Steps: File IDE Q1 17 followed by next trial Q2 17 9 EyeGate Ocular Bandage Gel (OBG) Data from First Human Clinical Trial 1. BCL = bandage contact lens and AT = artificial tears # Subjects Closed Wound: Day 3 Surface Area (mm 2 ) per arm # % Day 1 Day 3 Arm 1: OBG 12 10 83.3% 18.5 0.02 Arm 2: OBG + BCL 14 9 64.3% 40.7 0.10 Arm 3: BCL + AT 1 13 7 53.8% 39.5 0.37 Total Subjects Enrolled 39 OBG vs BCL: % better 54.8% 53.3% 94.4%

Meeting with FDA (Nov 2016) confirms device 510(k) de novo filing available for OBG Device - Indication for Use (IFU): Acceleration of re - epithelialization of large corneal epithelial defects in patients having undergone PRK Broader IFU: Demonstrate benefit in additional clinical trial(s) based on size of defect and not a specific underlying cause or indication Superiority claim against standard - of - care not necessary 10 EyeGate Ocular Bandage Gel (OBG) Device CMHA - S Promotes re - epithelization (wound healing) Accelerates re - epithelization Exhibits more normal epithelial and stromal organization and morphology RESULT: POTENTIALLY FASTER RESTORATION OF VISION AND BETTER VISUAL OUTCOMES

EyeGate has retained control of worldwide commercial rights to CMHA - S FDA 510(K) de novo filing targeted for year - end 2017 European CE Mark targeted for year - end 2017, commercializing H1 2018 EyeGate Ocular Bandage Gel (OBG) Surgeries : >4 million (~ 0.8 million prescriptions) R efractive surgeries ( PRK) Vitrectomies (Diabetics) Collagen crosslinking P re - cataract surgery Pterygium Ocular trauma: ~1.8 million (~0 .9 million prescriptions) Corneal foreign bodies A brasions / contusions C hemical burns D ifficult to heal alkali burns (PCED) Ocular/ Systemic Disorders: >50 million (~ 1.4 million prescriptions) Neu rotrophic keratitis (Herpes, Diabetes) Autoimmune disease ( Sjogrens ) GvHD Contact lens wear Ocular irritants Epithelial injury (exposure): ~16 million (~ 1.8 million prescriptions) Lid malposition (ectropion/entropion) Dry Eye Cranial Neuropathies Corneal Epitheliopathy: U.S. Numbers 1 11 1. Potential peak sales based on EyeGate internal estimates, and are subject to unknown factors including, but not limited to, c lin ical outcome, regulatory approval, payer negotiations and competition. Potential peak sales amounts assume a price range of $150 to $250 per prescription and approximately 4.8 mi lli on prescriptions per year. See Forward Looking Statements above. These numbers include all people at risk for corneal epitheliopathies. OBG POTENTIAL PROJECTED U.S. PEAK SALES: BETWEEN $720 million AND $1.2 billion 1

12 CMHA - S Solid or Film Formulations (2 Versions) Research Funded by Grants Desired Properties of the Film: Easy to place, requiring no sutures or glue Allows for immediate stabilization of the eye following trauma No refrigeration or freezer required: room stable Prevents adhesions and scar formation between the globe and the conjunctiva 2. NSF SBIR Grant: Phase II Status Films/Pellet: Topical sustained - release delivery vehicle placed in inferior fornix Release Profile: High - load product still releasing at 8 weeks ( in vitro study ongoing) Retention Rate: Re - engineering design for longer retention on eye Delivery vehicle for short or long - term acute or chronic conditions including Antibiotic: bacterial conjunctivitis/keratitis Antihistamine: seasonal/perennial allergies Prostaglandins: glaucoma 1. DoD SBIR Phase II Grant: Ocular Surface Shield A sterile, field - stable product easily applied to immediately protect and promote healing of the ocular surface

Small electrical current (constant); current has same charge as active substance (drug) Electrode creates repulsive electromotive forces (like charges repel) Drug migrates toward return electrode, mobility a function of molecular weight and charge Drug dose controlled by 2 variables: Current (mA) x application time (minutes) Easy to use: ophthalmologist or optometrist in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